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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97566

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 30, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
CareFusion 303, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 138905-01 138906-01 138907-01 138908-01 138909-01 138910-01 138911-01 138912-01 138913-01 138914-01 138915-01 138916-01 138917-01 138918-01 138919-01 138920-01 138921-01 138922-01 138923-01 138924-01 138926-01 138927-01 138928-01 138929-01 138930-01 138931-01 138932-01 138933-01 138934-01 138936-01 138937-01 138938-01 138939-01 138940-01 138941-01 138942-01 138943-01 138944-01 138945-01 138946-01 138947-01 138948-01 138949-01 138950-01 138951-01 138952-01 138953-01 138954-01 138955-01 138956-01 138957-01 138958-01 138959-01 138960-01 138961-01 138962-01 138963-01 138964-01 138965-01 138966-01 138967-01 138968-01 138969-01 138970-01 138971-01 138972-01 138973-01 138974-01 138975-01 138976-01 138977-01 138978-01 138989-01 138990-01 139000-01 139001-01 139002-01 139011-01 139013-01 139016-01 139018-01 139019-01 139020-01 139021-01 139022-01 139023-01 139028-01 139062-01 139063-01 139073-01 139082-01 139084-01 139085-01 139086-01 139091-01 139122-01 139125-01 139126-01 139127-01 139128-01 139131-01 139141-01 139142-01 139156-01 139163-01 139170-01 139171-01 139172-01 139174-01 139175-01 155081-01 155082-01 155083-01 155084-01 155085-01 155086-01 155087-01 155088-01 155089-01 155090-01 155091-01 155092-01 155093-01 155094-01 155095-01 155096-01 155097-01 155098-01 155099-01 155100-01 155101-01 155102-01 155103-01 155104-01 155105-01 155106-01 155107-01 155108-01 155109-01 155110-01 155111-01 155112-01 155113-01 155114-01 155115-01 155116-01 155117-01 155118-01 155119-01 155120-01 155121-01 155122-01 155123-01 155124-01 155125-01 155126-01 155127-01 155128-01 155129-01 155130-01 155131-01 155132-01 155133-01 155134-01 155135-01 155136-01 155137-01 155138-01 155139-01 155140-01 155141-01 155142-01 155143-01 155144-01 155145-01 155146-01 155147-01 155148-01 155149-01 155150-01 155151-01 155152-01 155153-01 155154-01 155155-01 155156-01 155157-01 155159-01 155160-01 155161-01 155163-01 155165-01 155166-01 155167-01 155168-01 155169-01 155171-01 155288-01 155293-01 155294-01 155299-01 155302-01 155303-01 155304-01 155305-01 155310-01 155311-01 169-03 169-04 169-05 169-06 169-07 169-08 169-09 169-10 169-100 169-101 169-102 169-103 169-104 169-105 169-106 169-107 169-108 169-109 169-11 169-110 169-111 169-112 169-113 169-114 169-115 169-12 169-120 169-124 169-125 169-127 169-128 169-129 169-13 169-131 169-132 169-137 169-138 169-139 169-14 169-140 169-141 169-142 169-143 169-144 169-145 169-15 169-150 169-151 169-152 169-155 169-156 169-159 169-16 169-160 169-161 169-162 169-163 169-164 169-18 169-19 169-20 169-21 169-22 169-23 169-24 169-25 169-26 169-27 169-28 169-29 169-30 169-31 169-32 169-33 169-34 169-35 169-36 169-37 169-38 169-39 169-40 169-41 169-42 169-43 169-44 169-45 169-46 169-47 169-48 169-49 169-50 169-51 169-52 169-53 169-54 169-55 169-56 169-57 169-58 169-59 169-60 169-61 169-62 169-63 169-64 169-65 169-66 169-67 169-68 169-69 169-70 169-71 169-72 169-73 169-74 169-75 169-76 169-77 169-78 169-79 169-80 169-81 169-82 169-83 169-84 169-85 169-86 169-87 169-88 169-89 169-90 169-91 169-92 169-93 169-94 169-95 169-96 169-97 169-98 169-99

Z-0367-2026
Recall number
Z-0367-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
CareFusion 303, Inc.
Quantity
8,262 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

Code information

All Serial Numbers/Ref #/UDI: 1137-00 N/A, 1145-00 10885403517167, 1146-00 10885403517174, 1147-00 10885403517181, 1148-00 10885403517198, 138902-01 N/A, 138903-01 N/A, 138905-01 N/A, 138906-01 N/A, 138907-01 N/A, 138908-01 N/A, 138909-01 N/A, 138910-01 N/A, 138911-01 N/A, 138912-01 N/A, 138913-01 N/A, 138914-01 N/A, 138915-01 N/A, 138916-01 N/A, 138917-01 N/A, 138918-01 N/A, 138919-01 N/A, 138920-01 N/A, 138921-01 N/A, 138922-01 N/A, 138923-01 N/A, 138924-01 N/A, 138926-01 N/A, 138927-01 N/A, 138928-01 N/A, 138929-01 N/A, 138930-01 N/A, 138931-01 N/A, 138932-01 N/A, 138933-01 N/A, 138934-01 N/A, 138936-01 N/A, 138937-01 N/A, 138938-01 N/A, 138939-01 N/A, 138940-01 N/A, 138941-01 N/A, 138942-01 N/A, 138943-01 N/A, 138944-01 N/A, 138945-01 N/A, 138946-01 N/A, 138947-01 N/A, 138948-01 N/A, 138949-01 N/A, 138950-01 N/A, 138951-01 N/A, 138952-01 N/A, 138953-01 N/A, 138954-01 N/A, 138955-01 N/A, 138956-01 N/A, 138957-01 N/A, 138958-01 N/A, 138959-01 N/A, 138960-01 N/A, 138961-01 N/A, 138962-01 N/A, 138963-01 N/A, 138964-01 N/A, 138965-01 N/A, 138966-01 N/A, 138967-01 N/A, 138968-01 N/A, 138969-01 N/A, 138970-01 N/A, 138971-01 N/A, 138972-01 N/A, 138973-01 N/A, 138974-01 N/A, 138975-01 N/A, 138976-01 N/A, 138977-01 N/A, 138978-01 N/A, 138989-01 N/A, 138990-01 N/A, 139000-01 N/A, 139001-01 N/A, 139002-01 N/A, 139011-01 N/A, 139013-01 N/A, 139016-01 N/A, 139018-01 N/A, 139019-01 N/A, 139020-01 N/A, 139021-01 N/A, 139022-01 N/A, 139023-01 N/A, 139028-01 N/A, 139062-01 N/A, 139063-01 N/A, 139073-01 N/A, 139082-01 N/A, 139084-01 N/A, 139085-01 N/A, 139086-01 N/A, 139091-01 N/A, 139122-01 N/A, 139125-01 N/A, 139126-01 N/A, 139127-01 N/A, 139128-01 N/A, 139131-01 N/A, 139141-01 N/A, 139142-01 N/A, 139156-01 N/A, 139163-01 N/A, 139170-01 N/A, 139171-01 N/A, 139172-01 N/A, 139174-01 N/A, 139175-01 N/A, 155081-01 10885403503870, 155082-01 10885403503887, 155083-01 10885403503894, 155084-01 10885403503900, 155085-01 10885403503917, 155086-01 10885403503726, 155087-01 10885403503733, 155088-01 10885403503740, 155089-01 10885403503757, 155090-01 10885403503764, 155091-01 10885403503771, 155092-01 10885403503788, 155093-01 10885403503795, 155094-01 10885403503801, 155095-01 10885403503818, 155096-01 10885403503696, 155097-01 10885403504198, 155098-01 10885403503702, 155099-01 10885403504204, 155100-01 10885403504211, 155101-01 10885403504228, 155102-01 10885403504235, 155103-01 10885403504242, 155104-01 10885403504259, 155105-01 10885403503719, 155106-01 10885403504266, 155107-01 10885403504273, 155108-01 10885403504280, 155109-01 10885403504327, 155110-01 10885403504297, 155111-01 10885403504303, 155112-01 10885403504099, 155113-01 10885403504105, 155114-01 10885403504112, 155115-01 10885403504129, 155116-01 10885403504136, 155117-01 10885403504143, 155118-01 10885403504150, 155119-01 10885403504334, 155120-01 10885403504167, 155121-01 10885403504174, 155122-01 10885403504181, 155123-01 10885403504082, 155124-01 10885403504075, 155125-01 10885403503658, 155126-01 10885403503665, 155127-01 10885403503672, 155128-01 10885403503689, 155129-01 10885403504341, 155130-01 10885403504358, 155131-01 10885403504365, 155132-01 10885403504372, 155133-01 10885403503542, 155134-01 10885403503559, 155135-01 10885403503566, 155136-01 10885403503573, 155137-01 10885403503597, 155138-01 10885403503603, 155139-01 10885403503610, 155140-01 10885403504440, 155141-01 10885403503580, 155142-01 10885403504457, 155143-01 10885403504464, 155144-01 10885403504471, 155145-01 10885403504488, 155146-01 10885403504754, 155147-01 10885403504761, 155148-01 10885403504778, 155149-01 10885403504785, 155150-01 10885403504792, 155151-01 10885403504709, 155152-01 10885403504716, 155153-01 10885403504723, 155154-01 10885403504730, 155155-01 10885403504747 155156-01 10885403504624, 155157-01 10885403504631, 155159-01 10885403504655, 155160-01 10885403504662, 155161-01 10885403504679, 155163-01 10885403504686, 155165-01 10885403504693, 155166-01 10885403504570, 155167-01 10885403504587, 155168-01 10885403504594, 155169-01 10885403504600, 155171-01 10885403504617, 155288-01 10885403508721, 155293-01 10885403509926, 155294-01 10885403509933, 155299-01 10885403510526, 155302-01 10885403510762, 155303-01 10885403510779, 155304-01 10885403510786, 155305-01 10885403510793, 155310-01 10885403510830, 155311-01 10885403510847, 169-03 10885403512575, 169-04 10885403512575, 169-05 10885403512575, 169-06 10885403512575, 169-07 10885403512575, 169-08 10885403512575, 169-09 10885403512575, 169-10 10885403512575, 169-100 10885403512568, 169-101 10885403512544, 169-102 10885403512544, 169-103 10885403512544, 169-104 10885403512544, 169-105 10885403512544, 169-106 10885403512544, 169-107 10885403512544, 169-108 10885403512544, 169-109 10885403512544, 169-11 10885403512575, 169-110 10885403512544, 169-111 10885403512544, 169-112 10885403512544, 169-113 10885403512544, 169-114 10885403512544, 169-115 10885403512544, 169-12 10885403512575, 169-120 10885403512551, 169-124 10885403512551, 169-125 10885403512551, 169-127 10885403512575, 169-128 10885403512575, 169-129 10885403512575, 169-13 10885403512575, 169-131 10885403512568, 169-132 10885403512568, 169-137 10885403512544, 169-138 10885403512568, 169-139 10885403512568, 169-14 10885403512575, 169-140 10885403512568, 169-141 10885403512575, 169-142 10885403512568, 169-143 10885403512568, 169-144 10885403512568, 169-145 10885403512568, 169-15 10885403512575, 169-150 10885403512544, 169-151 10885403512544, 169-152 10885403512544, 169-155 10885403512568, 169-156 10885403512568, 169-159 10885403512544, 169-16 10885403512575, 169-160 10885403512544, 169-161 10885403512544, 169-162 10885403512544, 169-163 10885403512544, 169-164 10885403512544, 169-18 10885403512575, 169-19 10885403512575, 169-20 10885403512575, 169-21 10885403512575, 169-22 10885403512575, 169-23 10885403512568, 169-24 10885403512568, 169-25 10885403512568, 169-26 10885403512568, 169-27 10885403512568, 169-28 10885403512568, 169-29 10885403512568, 169-30 10885403512568, 169-31 10885403512568, 169-32 10885403512568, 169-33 10885403512568, 169-34 10885403512568, 169-35 10885403512568, 169-36 10885403512568, 169-37 10885403512568, 169-38 10885403512568, 169-39 10885403512568, 169-40 10885403512568, 169-41 10885403512568, 169-42 10885403512568, 169-43 10885403512568, 169-44 10885403512568, 169-45 10885403512568, 169-46 10885403512568, 169-47 10885403512568, 169-48 10885403512568, 169-49 10885403512568, 169-50 10885403512568, 169-51 10885403512568, 169-52 10885403512568, 169-53 10885403512568, 169-54 10885403512568, 169-55 10885403512568, 169-56 10885403512568 169-57 10885403512568, 169-58 10885403512568, 169-59 10885403512568, 169-60 10885403512568, 169-61 10885403512568, 169-62 10885403512568, 169-63 10885403512568, 169-64 10885403512568, 169-65 10885403512568 169-66 10885403512568, 169-67 10885403512568, 169-68 10885403512568, 169-69 10885403512568, 169-70 10885403512568, 169-71 10885403512568, 169-72 10885403512568, 169-73 10885403512568, 169-74 10885403512568, 169-75 10885403512568, 169-76 10885403512568, 169-77 10885403512568, 169-78 10885403512568, 169-79 10885403512568, 169-80 10885403512568, 169-81 10885403512568, 169-82 10885403512568, 169-83 10885403512568, 169-84 10885403512568, 169-85 10885403512568, 169-86 10885403512568, 169-87 10885403512568, 169-88 10885403512568, 169-89 10885403512568, 169-90 10885403512568, 169-91 10885403512568, 169-92 10885403512568, 169-93 10885403512568, 169-94 10885403512568, 169-95 10885403512568, 169-96 10885403512568, 169-97 10885403512568, 169-98 10885403512568, 169-99 10885403512568

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.

device · product 2 of 5

Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-01 139046-01 139049-01 139051-01 139052-01 139053-01 139054-01 139055-01 139056-01 139058-01 139059-01 139060-01 139061-01 139064-01 139065-01 139066-01 139067-01 139068-01 139069-01 139070-01 139071-01 139072-01 139164-01 139165-01 300

Z-0368-2026
Recall number
Z-0368-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
CareFusion 303, Inc.
Quantity
2,755 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

Code information

All Serial Numbers/Ref #/UDI: 1119-00 10885403512704, 1139-00 10885403512704, 139038-01 N/A, 139039-01 N/A, 139040-01 N/A, 139041-01 N/A, 139043-01 N/A, 139044-01 N/A, 139045-01 N/A, 139046-01 N/A, 139049-01 N/A, 139051-01 N/A, 139052-01 N/A, 139053-01 N/A, 139054-01 N/A, 139055-01 N/A, 139056-01 N/A, 139058-01 N/A, 139059-01 N/A, 139060-01 N/A, 139061-01 N/A, 139064-01 N/A, 139065-01 N/A, 139066-01 N/A, 139067-01 N/A, 139068-01 N/A, 139069-01 N/A, 139070-01 N/A, 139071-01 N/A, 139072-01 N/A, 139164-01 N/A, 139165-01 N/A, 300 N/A

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.

device · product 3 of 5

Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00

Z-0369-2026
Recall number
Z-0369-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
CareFusion 303, Inc.
Quantity
32 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

Code information

All Serial Numbers/Ref #/UDI: 1149-00 10885403517822 and 1152-00 10885403517839

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.

device · product 4 of 5

BD Pyxis Pro MedStation Main, REF: 1155-00

Z-0370-2026
Recall number
Z-0370-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
CareFusion 303, Inc.
Quantity
27 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

Code information

All Serial Numbers/Ref #/UDI: 1155-00 10885403521300

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.

device · product 5 of 5

All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00

Z-0371-2026
Recall number
Z-0371-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
CareFusion 303, Inc.
Quantity
443 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

Code information

Ref #/UDI: 1116-00 10885403512605

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.

Field note

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